Publication of the implementing act of the Health Technology Assessment Regulation on information exchange with the EMA.
It has been published the Comission Implementing Regulations (EU) 2024/2699 of 18 October 2024 laying down, pursuant to Regulation (EU) 2021/2282 of the European Parliament and of the Council, detailed procedural rules for the cooperation of the Member State Coordination Group on Health Technology Assessment and the Commission with the European Medicines Agency (EMA).
- It sets out rules for cooperation with the EMA on the joint clinical evaluation of medicinal products, medical devices and in vitro diagnostic medical devices, and joint scientific consultation on medicinal products and medical devices.
- Entry into force: 20 days after publication in the Official Journal of the European Union and will apply from 12 January 2025.
The percentage of medicine shortages problems remains the same as in the last quarter of 2023.
The AEMPS has published the Report on supply problems for the first half of 2024. Specifically, its numbers tell us:
- Out of 32,986 authorised medicinal product presentations, 4.28% suffer from supply problems. Of this 4.28%, 0.33% have a major impact on patients.
- The AEMPS continues to undertake actions at a national level to prevent or mitigate medicine shortages.
REMINDER: The transition period for clinical trials on medicinal products to the European Regulation ends on 31 January.
By 31 January 2025, clinical trials with medicinal products that are still active after that date must be adapted to the CTIS.
Failure to transition to the new Regulation could lead to corrective measures by the AEMPS.
Commission fines Teva €462.6 million over misuse of the patent system and disparagement to delay rival multiple sclerosis medicine.
The Commission has fined Teva €462.6 million in the Copaxone (multiple sclerosis treatment) case for abuse of its dominant position. The Commission found that the infringer artificially extended the patent protection of Copaxone and systematically disseminated misleading information about a competing product in order to hinder its entry and acceptance on the market.
This is the first time that the Commission has imposed a fine in relation to such practices.
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